FDA advisory panel votes not to approve GSK's mepolizumab for COPD

At a meeting yesterday, the Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration gave a negative, non-binding opinion on the approval of the biological drug mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.

According to the drug’s maker, GlaxoSmithKline (LSE: GSK), the committee voted on the basis of data presented that the risk-benefit profile was not adequate to support approval (3 for, 16 against).

The committee also voted that there was not substantiaidence of the efficacy (3 for, 16 against) but there was adequate evidence of the safety (17 for, 2 against) of mepolizumab in this population and the committee suggested further data to characterize the patient population that would be most likely to benefit from this targeted biologic therapy.